布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.038356983162834058382283480834880.29
211.028248582868826760.33
单位质量响应值RSD%判断
7569.177502.360.63数据可信
供试品溶液-2821374批-pH4.3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min144259-4425952.59554.187.9752.6054.187.96
246779-4677955.59055.59
345010-4501053.48853.49
452261-5226162.10562.10
542902-4290250.98350.98
642330-4233050.30350.30
15min170304-7030483.54684.912.1384.1385.522.16
271872-7187285.41086.03
370040-7004083.23283.83
474118-7411888.07988.77
571804-7180485.32985.90
670575-7057583.86884.43
20min173006-7300686.75787.602.3388.2789.142.34
274452-7445288.47590.04
371843-7184385.37586.89
475608-7560889.84991.52
575496-7549689.71691.23
671879-7187985.41886.91
30min176976-7697691.47591.872.1293.9594.392.13
276909-7690991.39593.95
375241-7524189.41391.88
479400-7940094.35597.02
579125-7912594.02996.54
676221-7622190.57893.02
45min178401-7840193.16893.621.3196.6697.161.36
279086-7908693.98297.55
377542-7754292.14895.61
480177-8017795.27998.99
579635-7963594.63598.19
677847-7784792.51095.96
60min177573-7757392.18493.021.6796.7197.601.70
278736-7873693.56698.18
376508-7650890.91995.40
480125-8012595.21799.99
579126-7912694.03098.64
677566-7756692.17696.65
极限178520-7852093.31093.851.3598.8699.461.34
280065-8006595.146100.79
377344-7734491.91297.41
479022-7902293.90699.74
580204-8020495.311100.96
678701-7870193.52599.02
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)10补液体积(ml)10
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.038283682722828928299682992828880.14
211.028312183337832290.19
单位质量响应值RSD%判断
7514.787552.540.36数据可信
供试品溶液-25082601批-pH4.3
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
10min118894-1889422.45922.685.7522.4622.685.75
220919-2091924.86624.87
317690-1769021.02821.03
418357-1835721.82021.82
519229-1922922.85722.86
619409-1940923.07123.07
15min139876-3987647.40047.895.5247.6548.145.50
242093-4209350.03550.31
341977-4197749.89750.13
437646-3764644.74944.99
537689-3768944.80045.05
642454-4245450.46450.72
20min142987-4298751.09757.726.2451.8758.506.18
249818-4981859.21760.05
350193-5019359.66360.45
448181-4818157.27158.01
548407-4840757.54058.29
651773-5177361.54162.36
30min151361-5136161.05165.874.4562.4067.304.43
257593-5759368.45969.95
358176-5817669.15270.60
454256-5425664.49365.87
555278-5527865.70767.10
655830-5583066.36467.86
45min156851-5685167.57770.584.1269.6072.744.08
262618-6261874.43276.68
361606-6160673.22975.45
457190-5719067.98070.07
560206-6020671.56573.69
657790-5779068.69370.93
60min156263-5626366.87872.844.6069.6575.784.54
263310-6331075.25578.33
362076-6207673.78876.82
459944-5994471.25474.10
563961-6396176.02978.95
662129-6212973.85176.85
极限160169-6016971.52173.532.7275.0477.282.76
263934-6393475.99779.91
363697-6369775.71579.57
460370-6037071.76075.40
560750-6075072.21275.97
662247-6224773.99177.81
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